LASIK News and Information. Hard-Hitting Reporting on the LASIK Industry.

The Scandal of LASIK

Imagine a surgical procedure being performed for non-medical reasons on a healthy organ critical to our ability to function. Considering that this surgery neither treats nor prevents disease, what is its acceptable rate of serious and permanent complications? Shouldn’t it be zero? How can we even consider it being far greater than those of vaccinations that, while also given to healthy people, provide invaluable disease-prevention benefits? LASIK/PRK laser surgeries do not.

How has it been possible that the well-documented, disastrous, permanent complications of these procedures have been ignored by the FDA–never mind the eye care professions? I have a confession to make. Despite my having been aware of the many blinding consequences of this surgery having treated many of them when I worked at the Boston Foundation for Sight (which I founded but no longer am affiliated with), I too failed to act on my observations that these surgical procedures can destroy the quality of life of these victims.

I did nothing until I became aware of a complication that had not been previously reported; long lasting and in many cases, probably permanent suicide-provoking eye pain. This is not the pain that many patients experience after the surgery. Why hasn’t this devastating complication been previously reported? The answer, I had assumed, was that eye doctors had been misled because these eyes typically look normal and well healed. And since, we have been trained to believe that the cause of chronic eye pain can always be identified during traditional examinations and that if nothing is found to explain it, this devastating eye pain must be imaginary. Moreover, as I discovered, the onset of this type of pain can occur years after the surgery and its connection to the surgery easily dismissed. I hadn’t even considered that there could be a coordinated effort to suppress this information.

I did detailed examinations on 21 such patients (how rare can it be?) and wrote a paper detailing the characteristics of this pain disease which I call corneal neuropathic centralized pain. I explained why it differs from typical temporary post operative pain. In it I presented my theory about its mechanisms and included suggestions on how it might be possibly prevented. Shouldn’t it be of interest to eye doctors, the FDA and prospective patients? In fact, it was summarily rejected by a leading peer-reviewed journal in ophthalmology. I shrugged my shoulders and submitted it to one that specializes in corneal laser procedures, fully expecting it to be accepted. It too was rejected outright for reason, according to the reviewers, that were impossible to address. I could have explained that, because of the infrequency of this complication, it would take more than 15 years at an incredible cost to perform the studies they insisted would be needed by other journals. In other words their suggestions were beyond the pale. Nor was I allowed to respond. The decision was irreversible. I was confused. So I sent the paper to world-class pain researchers for their opinions. All supported its being published. (One called my work “transformative”.) It is interesting that both journals ignored my recommendation that at least one of the reviewers be an expert in pain. I began to wonder if they had a hidden agenda. Was I becoming paranoid?

As I began to read the history of LASIK and its complications I became aware of the central role of the FDA in continuing to sanction these procedures despite their history. So I sent my paper to the FDA to document this previously unreported complication despite being warned that they will not respond. I didn’t believe it. I was wrong. I sent the paper twice without it even being acknowledged. Of course they could always say that the paper has no standing because it had been rejected. However, a cursory look at the results of any search engines provides a day’s read. Where is the shame?

I would never have imagined that editors of scientific peer-reviewed journals, a vast, profitable manufacturing/marketing industry and even some practicing doctors would collaborate to hide these complications from the public and prospective patients. And what about the government agency whose primary responsibility is to protect the public?

As of 2011, it was estimated that more than 11 million of these procedures had been performed in the US. (http://bmctoday.net/crstodayeurope/2013/02/article.asp?f=ndyag-treatment-of-epithelial-ingrowth) and more than 28 million have been done world-wide (http://www.aao.org/publications/eyenet/200906/feature.cfm?) and it was predicted that at the current rate of 800,000 procedures per year, the available pool of surgical candidates is growing by 2 million eyes per year (http://bmctoday.net/crstoday/2011/08/article.asp?f=the-lasik-market-yesterdays-technology-or-poised-for-recovery). This is a huge industry with tentacles that appear to reach the bowels of the FDA. In the meantime, I think about what will be happening to the vast numbers of the people who will be undergoing these procedures ignorant of their possible life-destroying complications. Shouldn’t they at least be able to make an informed decision?

I have been accused as having an over-abundance of naivety. But, I can no longer be silent.